Events

Recall of Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of a portable/mobile radiological imaging system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01217-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01217-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Philips has recently performed evaluations of the mobile detector holder and has identified a potential issue that may affect the performance of the equipment under certain conditions. if the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. this may happen when the detector is rotated clockwise from landscape to portrait position.The wireless portable detector (wpd) is fixed in the mobile detector holder via a lock mechanism. the 4 countersunk screws, that are used to attach the lock mechanism, can become loose. if this happens and the mechanism fails, the detector may fall down when the holder is rotated 90° clockwise from landscape.
  • Action
    1. Users should read the notice and check the lock mechanism of the Mobile Detector Holder. The lock mechanism can be moved without pressing the actuator, the holder should not be rotated clockwise. a. Distribute the notice to all users of the device and complete the supplied response form and return it to. Philips via fax/email within three (3) business days. b. Philips will contact users to schedule a correction to the affected units.

Device

Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of...
  • Model / Serial
    Mobile Detector Holder Trolley (9890-010-88152) (used to support the transport and utilisation of a portable/mobile radiological imaging system)ARTG Number: 293924
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA